Xinjing Zhiyuan's Autologous TCR-T Cell Therapy Candidate NW-101C Receives IND Approval in China for Advanced Solid Tumors

Recently, Neowise Biotechnology, Co., Ltd. (hereinafter referred to as "Neowise Biotechnology"), a biotechnology company focused on the research and development of TCR-T immunotherapy drugs for solid tumors, announced its self-developed autologous TCR-T cell therapy candidate product targeting PRAME.NW-101C InjectionThe Investigational New Drug (IND) application has received the tacit approval for clinical trials from the National Medical Products Administration (NMPA).

This is the first investigational product of Neowise Biotechnology to receive regulatory approval for clinical trials, marking a critical step forward in the company’s development of TCR-T cell therapy drugs. Meanwhile,NW-101C injection is also the first domestically produced candidate product in China to be approved for clinical research targeting the PRAME antigen in TCR-T cell therapy., filling the gap in this field.

NW-101C Injection is a self-developed autologous TCR-T cell therapy candidate product by Neowise Biotechnology, targeting PRAME. PRAME is a tumor antigen target that is highly expressed in various solid tumors but has almost no expression in normal tissues. In preclinical studies, NW-101C Injection demonstrated excellent anti-tumor activity and good safety. The approved indication for NW-101C this time isHLA TypingAdvanced malignant solid tumors (including ovarian cancer, malignant melanoma, esophageal squamous cell carcinoma, squamous cell carcinoma of the lung, soft tissue sarcoma, and triple-negative breast cancer) that are HLA-A*02:01 subtype-positive, PRAME-expressing, and unresectable or recurrent/metastatic.

Neowise Biotechnology, Co., Ltd. is an innovative enterprise focused on the development of TCR-T immunotherapy drugs for solid tumors. Neowise Biotechnology has independently developed a high-throughput, high-sensitivity target antigen-natural TCR discovery platform. By combining computational and experimental iterative feedback validation, it efficiently screens natural high-affinity TCR sequences that specifically recognize tumor antigens, establishing a globally leading experimentally-validated target antigen-natural TCR pairing database. The company currently has multiple pipelines that have advanced to the clinical trial stage, and positive efficacy and good safety have been observed in clinical trials targeting various solid tumors.

Source: Neowise Biotechnology